EUCTR2010-019547-19-IT进行中（未招募）不适用
A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years - AMB112529
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female at least 8 years of age and not yet 18 years of age at the time of
- •randomization.
- •2. A current diagnosis of PAH (WHO Group 1) with WHO class II or III symptoms in
- •one of the following categories:
- •Idiopathic
- •Heritable [familial]
- •Secondary to connective tissue disease (e.g., limited scleroderma, diffuse
- •scleroderma, mixed connective tissue disease (CTD), systemic lupus
- •erythematosus, or overlap syndrome).
- •Persistent PAH despite surgical repair (at least 6 months prior to the screening
- •visit) of atrial septal defects, ventricular septal defects, atrio-ventricular septal
- •defects, and persistent patent ductus.
- •3. Have met the following hemodynamic criteria for subjects with right heart
- •catheterization (RHC) when performed as part of the diagnosis or routine care (see
- •Appendix 1):
- •mean pulmonary arterial pressure (mPAP) of =25 mmHg
- •pulmonary vascular resistance (PVR) of =240 dyne·sec/cm5
- •left ventricular end diastolic pressure (LEVDP) or pulmonary capillary wedge
- •pressure (PCWP) of =15 mmHg.4. Subjects must either be treatment na?ve, have discontinued treatment with another
- •ERA (e.g., bosentan) at least 1 month previously because of elevated liver function
- •tests (LFTs), or have been on a stable dose of drug therapy for PAH (e.g., sildenafil
- •or prostacyclin) for at least one month prior to the Screening Visit. The baseline
- •drug therapy for PAH, if any, should not change from the Screening Visit until the
- •end of all Treatment Period assessments.
- •5. Subjects who discontinued ERA treatment due to elevated LFTs, must have LFTs of
- •<3 x Upper Limit of Normal (ULN).
- •6. A female is eligible to participate in this study, as assessed by the investigator, if she
- •a. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant);
- •b. Child-bearing potential - has a negative pregnancy test and is not lactating at the
- •Screening and Baseline/Randomisation Visits and, if sexually active, agrees to use 2
- •reliable methods of contraception from the Screening Visit until study completion
- •and for at least 30 days following the last dose of study drug (reliable methods of
- •contraception are listed in Appendix 2).
- •7. Subject or subject’s legal guardian is able and willing to give written informed
- •consent. As part of the consent, female subjects of childbearing potential will be
- •informed of the risk of teratogenicity and will need to be counselled in a
- •developmentally appropriate manner on the importance of pregnancy prevention; and
- •male subjects will need to be informed of potential risk of testicular tubular atrophy
- •and aspermia.
- •Complete information regarding warnings, precautions, contraindications, adverse events,
- •and other pertinent information on the investigational product that may impact subject
- •eligibility is provided in the Investigators Brochure and product label.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects currently taking an ERA.
- •2. Subjects currently taking cyclosporine A.
- •3. Subjects whose body weight is less than 20 Kg.
- •4. Subjects who have not tolerated PAH therapy due to adverse effects which may be
- •related to their mechanism of action (e.g., prostanoids, ERA, PDE-5 inhibitors) with
- •the exception of liver abnormalities for those subjects who were receiving another
- •5. Female subjects who are pregnant or breastfeeding.
- •6. Subjects with diagnosis of active hepatitis (hepatitis B surface antigen and hepatitis
- •C antibody), or clinically significant hepatic enzyme elevation (i.e., ALT, AST or AP
- •>3xULN) at Screening.
- •7. Subjects with severe renal impairment (creatinine clearance <30 mL/min) at
- •8. Subject has clinically significant fluid retention in the opinion of the investigator.
- •9. Subject has clinically significant anaemia in the opinion of the investigator.
- •10. Subject has a known hypersensitivity to the study drug, the metabolites, or
- •formulation excipients.
- •11. Subjects who have participated in another trial or have taken another investigational
- •product during the previous 30 days.
- •12. Alcohol abuse, illicit drug use within 1 year.
- •13. Any concurrent condition or concurrent use of medication that would affect subject
- •safety in the opinion of the investigator.
研究者
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